Make Plans to attend MDCI’s complimentary seminar addressing Adaptive Clinical Trials and Conduct of Medical Device Clinical Trials MDCI, an Aptiv Solutions company is hosting a seminar November, 9, 2011 that tackles two subject areas that are important for life science and device companies. The complimentary, no-fee seminar is scheduled to take place the afternoon [...]

September 7, 2011 – Aptiv Solutions, a global biopharmaceutical and medical device development services company, and MDCI, an Aptiv Solutions company, announced today that several of its thought leaders will be presenting at the upcoming Q1 conferences, “Medical Device Regulatory Clearance and Approval” and the “2nd Annual Clinical Affairs and Regulatory Approvals for Diagnostics”, located [...]

News MDCI Welcomes Frederick Tobia as Director of Regulatory and Clinical Services In this new role, Tobia will oversee daily operations of medical device regulatory and CRO services Medical Device Consultants, Inc. (MDCI), a leading regulatory consulting firm and CRO for the medical device industry, announced today that Mr. Frederick (Fred) Tobia has joined the [...]

News July 18, 2011 MDCI Welcomes Brian Edwards, Senior Regulatory Staff Consultant Medical Device Consultants, Inc. (MDCI), a leading regulatory consulting firm and CRO for the medical device industry, announced today that Mr. Brian Edwards has joined the company’s regulatory services group as a senior regulatory staff consultant. He will be based in Minneapolis, MN. [...]

News February 1, 2011 MDCI to Present at the SAS Global Forum The company will present two useful techniques to allow SAS programmers to simplify and automate common statistical data activities using Excel and PowerPoint Mr. Laiju Zhang, MDCI’s senior manager of biostatistics and SAS programming will present at the SAS Global Forum in Las [...]

News December 22, 2010 MDCI to Co-Sponsor Medical Device Clinical Trials Forum December 22, 2010 – MDCI is pleased to announce that it will co-sponsor the Medical Device Clinical Trials Forum, to be held in conjunction with the 2011 Partnerships in Clinical Trials, March 31, 2011 at the Phoenix Convention Center, in Phoenix, Arizona. The [...]

News December 21, 2010 MDCI is pleased to sponsor the free InHealth Webcast, “Agency, Industry, and the 510(k) Process” For medical device manufacturers doing business in the United States, the primary route to market has historically been provided by FDA’s premarket notification (510(k)) product review process. But in recent years, the effectiveness of the 510(k) [...]

News August 2, 2010 MDCI to present “Medical Device Complaint Handling: What the New FDA Wants to See Today (and How to Show Them)” On August 4, 2010, Judy Andrews, Director of Quality and Compliance Services, will present a 90-minute webinar to discuss the changing FDA compliance environment, which includes greater emphasis on complaint investigation [...]

News June 2, 2010 Medical Device Consultants, Inc. Completes Successful FDA Inspection June 2, 2010, North Attleboro, MA – Medical Device Consultants, Inc. (MDCI), a full-service regulatory consulting firm and contract research organization (CRO) serving the medical device and diagnostics industry, underwent a routine surveillance inspection by the FDA, March 3 through March 16, 2010, [...]